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      Natural orifice surgery: initial clinical experience

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          Abstract

          Background

          Natural orifice translumenal endoscopic surgery (NOTES) has moved quickly from preclinical investigation to clinical implementation. However, several major technical problems limit clinical NOTES including safe access, retraction and dissection of the gallbladder, and clipping of key structures. This study aimed to identify challenges and develop solutions for NOTES during the initial clinical experience.

          Methods

          Under an Institutional Review Board (IRB)-approved protocol, patients consented to a natural orifice operation for removal of either the gallbladder or the appendix via either the vagina or the stomach using a single umbilical trocar for safety and assistance.

          Results

          Nine transvaginal cholecystectomies, one transgastric appendectomy, and one transvaginal appendectomy have been completed to date. All but one patient were discharged on postoperative day 1 as per protocol. No complications occurred.

          Conclusion

          The limited initial evidence from this study demonstrates that NOTES is feasible and safe. The addition of an umbilical trocar is a bridge allowing safe performance of NOTES procedures until better instruments become available. The addition of a flexible long grasper through the vagina and a flexible operating platform through the stomach has enabled the performance of NOTES in a safe and easily reproducible manner. The use of a uterine manipulator has facilitated visualization of the cul de sac in women with a uterus to allow for safe transvaginal access.

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          Most cited references23

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          Flexible transgastric peritoneoscopy: a novel approach to diagnostic and therapeutic interventions in the peritoneal cavity.

          A novel endoscopic peroral transgastric approach to the peritoneal cavity was tested in a porcine model in acute and long-term survival experiments. Transgastric peritoneoscopy was evaluated in 50-kg pigs. After upper endoscopy, the peritoneal cavity was accessed by needle-knife puncture of the gastric wall, followed by extension of the incision either with a pull-type sphincterotome or by balloon dilation. The peritoneal cavity was examined, and a liver biopsy specimen was obtained. The gastric wall incision was closed with clips. Twelve acute and 5 survival experiments were performed. Both techniques of gastric wall incision were without complication. The acute experiments demonstrated the technical feasibility of the approach. In the survival experiments, all pigs recovered and gained weight. The peroral transgastric approach to peritoneal cavity technically is feasible and has the potential to be an alternative to laparoscopy and laparotomy.
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            A primer on natural orifice transluminal endoscopic surgery: building a new paradigm.

            Access to the abdominal cavity is required for diagnostic and therapeutic endeavors for a variety of medical and surgical diseases. Historically, abdominal access has required a formal laparotomy to provide adequate exposure. Natural orifice transluminal endoscopic surgery (NOTES) is an emerging experimental alternative to conventional surgery that eliminates abdominal incisions and incision-related complications by combining endoscopic and laparoscopic techniques to diagnose and treat abdominal pathology. During NOTES, commercially available flexible video endoscopes are used to create a controlled transvisceral incision via natural orifice access to enter the peritoneal cavity. Common incision-related complications such as wound infections, incisional hernias, postoperative pain, aesthetic disdain, and adhesions could be minimized or eliminated by NOTES. NOTES has evolved from more than 2 centuries of technological innovations and continued growth in the field of surgical endoscopy. Innovative surgical endoscopists have slowly developed means to surpass the constraints of the gastrointestinal lumen by using a flexible endoscope. The future of surgical endoscopy may be the shared entity of NOTES, which further integrates endoscopy, gastroenterology, and minimally invasive and general surgery. Although the promise of NOTES is electrifying to surgeons and endoscopists, several key issues need to be characterized prior to the incorporation of NOTES into routine practice. This article reviews the status, contemporary body of literature, limitations, and potential future implications accompanying the development of NOTES.
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              NOTES transvaginal cholecystectomy: preliminary clinical application.

              Natural orifice translumenal endoscopic surgery (NOTES) is an emerging concept in the recent literature that could lead to potential benefits in clinical applications. Restricted to animal experiments, however, human procedures have not yet been published. Because of the technical and ethical challenges involved in perforation and closure of a healthy organ-as is also seen in operating via the transgastric route-and because of the lack of understanding of the physiopathology and infection risk with these approaches, they have not been applied in the clinical setting. Thus the present study, based on previous animal experiments, describes preliminary clinical application in four cases of transvaginal NOTES cholecystectomy, and discusses safety, feasibility, and potential benefits of the method. Preliminary acute and survival animal experiments developed by the NOTES Research Group at our institution solved such technical problems for transvaginal NOTES as spatial orientation, insufflation, and instrumentation, making possible the introduction of NOTES as a clinical application. The trials were approved by ethics committee of our institution, and informed consent was obtained from all patients. Since 13 March 2007, four female patients with elective surgical indication for cholecystectomy have undergone transvaginal NOTES cholecystectomy. All intraoperative and postoperative parameters were documented. Vaginal access was achieved under direct vision with conventional instruments, and a 2-channel colonoscope was inserted into the abdominal cavity. After endoscopic insufflation to achieve pneumoperitoneum with CO(2), instruments were inserted through and alongside a colonoscope, allowing successful NOTES cholecystectomy in all patients, with vaginal extraction of the gallbladder. The vaginal wound was closed by direct vision using conventional instruments. The procedure was successful in all patients, with operative time of 45-115 min. Patients experienced low need for postoperative analgesia. Free oral intake was permitted 2 h after the procedure. There were no postoperative complications, and patients were discharged, according to the study protocol, 48 h after the procedure. Preliminary results showed the feasibility and safety of the transvaginal NOTES method in this small initial study population. The technique, developed in our institution, and not transgastric NOTES, may be the preferred approach to serve as the basis for clinical studies.
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                Author and article information

                Contributors
                jcullen@ucsd.edu
                Journal
                Surg Endosc
                Surgical Endoscopy
                Springer-Verlag (New York )
                0930-2794
                1432-2218
                3 April 2009
                July 2009
                : 23
                : 7
                : 1512-1518
                Affiliations
                [1 ]Department of Surgery, University of California San Diego, 200 W. Arbor Drive, 8402, San Diego, CA 92103 USA
                [2 ]Department of General Surgery, Buenos Aires Hospital de Clinicas, Buenos Aires, Argentina
                [3 ]Department of Gastroenterology, University of California San Diego, San Diego, CA USA
                [4 ]Department of Reproductive Medicine, University of California San Diego, San Diego, CA USA
                Article
                428
                10.1007/s00464-009-0428-0
                2695868
                19343435
                a3b44ad1-a174-4d25-ad3b-55991ec48283
                © The Author(s) 2009
                History
                : 11 September 2008
                : 14 January 2009
                : 11 February 2009
                Categories
                Article
                Custom metadata
                © Springer Science+Business Media, LLC 2009

                Surgery
                surgical,endoscopy,cholecystectomy,appendix,clinical papers, trials, research
                Surgery
                surgical, endoscopy, cholecystectomy, appendix, clinical papers, trials, research

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